A First-in-Human (FIH), Phase I/II, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Preliminary Antitumor Activity of Zn-Telomir Administered Orally as Monotherapy in Patients With Advanced or Metastatic Triple-Negative Breast Cancer (TNBC)
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 76
研究概览
简要总结
This is a first-in-human, multicenter, open-label Phase I/II study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of oral Zn-Telomir monotherapy in adults with advanced or metastatic triple-negative breast cancer. Phase I uses a modified 3+3 dose-escalation design to determine safety, tolerability, maximum tolerated dose, and recommended Phase II dose. Phase II uses a Simon two-stage expansion design at the recommended Phase II dose to evaluate preliminary antitumor activity, including objective response rate per Response Evaluation Criteria in Solid Tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically defined histologically or cytologically confirmed triple-negative breast cancer (TNBC)
- •Locally advanced unresectable or metastatic disease
- •Must have completed prior anticancer therapy discontinued for a least 28 days
- •Disease progression after prior systemic therapy for advanced/metastatic TNBC
- •At least one measurable lesion (tumor)
- •Age ≥18 years
- •Life expectancy ≥12 weeks
- •Agreement to use highly effective contraception during study and for 3 months after treatment
- •Ability to understand and sign informed consent
排除标准
- •HER2-positive or hormone receptor-positive breast cancer
- •Active leptomeningeal disease
- •Uncontrolled, symptomatic CNS metastases
- •Concurrent participation in another interventional clinical trial
- •Clinically significant cardiovascular disease
- •Uncontrolled infection requiring systemic therapy
- •Known Human Immunodeficiency Virus (HIV) with detectable viral load >400 copies/mL
- •Active hepatitis B virus (HBV) infection or active hepatitis C virus (HCV)
- •Significant Gastrointestinal (GI) disorders
- •Active bleeding disorders or coagulopathy
- •Pregnancy or breastfeeding
研究组 & 干预措施
Phase II Dose Expansion
Participants receive oral Zn-Telomir at the recommended Phase II dose once daily on Days 1-14 of each 28-day cycle for up to 4 cycles, if tolerated.
干预措施: Zn-Telomir (Drug)
Phase I Dose Escalation
Participants receive oral Zn-Telomir once daily on Days 1-14 of each 28-day cycle at assigned cohort dose levels of 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 400 mg. Number of cycles will vary based on dose level and tolerability.
干预措施: Zn-Telomir (Drug)